Director, Principal Scientist Device Regulatory Compliance

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Senior

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Director, Principal Scientist Device Regulatory Compliance will be a key member of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). This role is primarily responsible for ensuring regulatory compliance for the company's portfolio of medical devices and combination products, while leading cross-functional teams to standardize global medical device requirements across various regions.

Responsibilities

• Lead a cross-functional team to standardize global medical device requirements including US, EU, UK, Switzerland, Canada, Japan, Australia, and Brazil.
• Stay abreast of evolving global regulatory landscapes for medical devices and combination products.
• Support generation of external surveillance reports of new and revised regulations, final guidance, and standards.
• Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback and global regulatory trends.
• Collaborate with GRACS, Device, Development & Technology (DD&T), purchasing, and manufacturing quality teams to ensure regulatory requirements are integrated into product development and manufacturing processes.
• Develop implementation strategies to align the QMS with identified regulatory updates.
• Support device sites with the collection and analysis of data for management review.

Requirements

• Bachelor's degree in a Science, Engineering, or a related field.
• At least 5 years of experience working in Pharmaceutical, Medical Device, or Biotech Industry.
• Recent experience interfacing with regulatory agencies such as FDA, EMA, or EU Notified Body.
• Recent experience participating in Notified Body Audits.
• Must be proficient in English.

Nice-to-haves

• Experience performing external surveillance of global device regulations.
• Experience with authoring and reviewing regulatory submissions.
• Experience performing gap analysis of quality systems against ISO 13485, MDSAP, EU MDR, EU IVDR and other global device regulations.
• Experience obtaining CE Marking for Medical Devices and Notified Body Opinion (NBOp) for drug delivery combination products.
• Prefer at least 3 years demonstrated leadership experience with project teams.